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Strong fit if you already work in regulatory operations or adjacent quality/compliance support, handle detail under deadlines, and prefer structured process work over pure strategy roles. This Loyal role is listed for the United States and is not marked remote, so willingness to work from the assigned U.S. location matters as much as technical regulatory hygiene.
As a Senior Associate Specialist in Regulatory Operations at Loyal, a typical day centers on keeping submissions, filings, and related records accurate and on schedule. You would track regulatory timelines, coordinate documents with cross-functional partners, check packages against requirements, and flag gaps before they delay review. Expect status updates, version control of controlled materials, and follow-through on queries from internal stakeholders so operations stay audit-ready.
The listing is for the United States and is not marked remote, so plan for on-site or hybrid arrangements as Loyal defines them for this team.
For a Senior Associate Specialist title, focus is typically process execution: documentation control, submission readiness, timeline tracking, and clean handoffs—not inventing policy from scratch.
Only a United States-level location is provided; no city, office address, or site-specific amenities are in the source data.
Senior Associate Specialist, Regulatory Operations at Loyal, United States - Full Time, No Remote About the Role We are seeking an experienced Sr. Associate Specialist, Regulatory Operations to join our team and support our day-to-day regulatory operations that drive our programs forward. This role requires a deep understanding of operational aspects such as compiling and formatting regulatory submissions, electronically submitting materials to the FDA/CVM, and managing trackers for ongoing projects. Responsibilities Compile and format regulatory submissions in compliance with FDA/CVM guidelines Electronically submit materials to the FDA/CVM on a regular basis Create, own, and update trackers for our ongoing submission processes Contribute to the regulatory path towards FDA CVM approval of novel longevity therapeutics Collaborate with cross-functional teams to ensure efficient and accurate regulatory filings Qualifications This role is ideal for someone with at least 3 years of experience in Regulatory Operations. Key qualifications include: Familiarity with the operational aspects of regulatory affairs Experience in compiling and formatting regulatory submissions Ability to manage and update trackers for ongoing projects Comfort collaborating with cross-functional teams About Loyal Loyal is a clinical-stage veterinary medicine company dedicated to developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives by pioneering new categories of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging. We have made significant progress toward our first regulatory approvals with additional submissions targeted in the near future. Next Steps To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.
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